drug dispensing

• the preparation, packaging, labeling, record keeping, and transfer of a prescription drug to a patient or an intermediary, who is responsible for administration of the drug.

• provision of drugs or medicines as set out properly on a lawful prescription. A prescription can only be filled, the drugs supplied, by a registered pharmacist, veterinarian, dentist or member of the medical profession. The law requires that a prescription be written only for patients that are in the veterinarian's care.

The PrescriptionA prescription is an order for medication issued by a physician, dentist, veterinarian or other properly licensed medical practitioner. It designate a specific medication and dosage to be administered to a particular patient at a specific time.

• History• The concept of prescriptions date back to the

beginning of history. So long as there were medications and a writing system to capture directions for preparation and usage, there were prescriptions .

• The prescription order is a part of the professional relationship between the prescriber, pharmacist and patient.

• It is the pharmacist responsibility in this relationship to provide the medication needs of the patient.

• The pharmacist must be precise , not only in the manual aspects of filling the prescription order ,but must provide the patient with the necessary information and guidance to assure the patient’s compliance in taking the medication properly.

• It is also the pharmacist’s responsibility to advice the prescriber of drug sensitivities the patient may have.

• To meet these responsibilities it is essential that the pharmacist maintain a high level of practice competence, keeps appropriate records on the health status and medication history of the patients and develop professional working relationships with other health professionals.

• In this role the pharmacist must maintain the trust of the prescriber and patient. This trust includes maintaining confidentiality. The medication being taken by a patient and the nature of his illness is a private matter which must be respected.

• There are two broad classification of medications: 1. those which can be obtained only by prescription. (prescription drugs)

• 2. those which may be purchased without a prescription. ( non-prescription drugs or over the counter drugs)

• Prescriptions may be written by the prescriber and given to the patient for presentation at the pharmacy, or they may be telephoned or communicated directly to the pharmacist.

• A prescription must be neat and legible. This point has become a formula but that does not diminish its importance. No one is insisting that a prescription be a model of lettering but the ink and the handwriting must be clear and decipherable.

• The prescription must be written on a letterhead so that the doctor can be identified and contacted if clarifications are necessary.

• The prescription must have a date.

• Patients identification information must be complete. This implies that the full name and the postal address of the patient be noted down along with age and sex.

• Drug names should be spelt correctly and should not be abbreviated.

• The exact number of the doses or the exact duration of the drug use should be specified rather than leaving the patient and pharmacist guessing as to the quantity that should be dispensed.

• The dosing frequency and the timing of drugs with meals, if any, should also be specified unambiguously. These matters often cause considerable unnecessary worry to the patients and their relatives.

• Special instructions for the pharmacist, if any, should also be written down explicitly rather than depending upon patients to convey them The prescription must always be signed.

• It should be revised after writing.

• Finally, the prescription must be explained clearly to the patients or their attendants. This is all the more important in in other countries as prescriptions may not be written down in vernacular languages or the patients may be illiterate.

• The doctor must be sure that the use of special formulations, for example dispersible tablets, has been correctly understood by the patient.

• Prescriptions are usually written on printed forms that contain blank spaces for the required information. These forms are called prescription blanks and are supplied in the form of pad.

• Prescription blanks that are utilized by physicians are imprinted with the name, address, telephone number and other pertinent information of the physician.

• Component parts of a prescription may be identified as follows:

• 1. patient information• 2.Date• 3.Rx symbol (superscription)• 4.Medication prescribed (inscription)• 5.Dispensing direction to pharmacist (subscription)• 6.Direction for patient or signa• 7.Refill, special labeling and/or other instruction• 8.Prescriber’s signature, address, and other

pertinent information

Processing the prescription order• The manner in which a pharmacist processes

a prescription order is important in fulfilling his professional responsibilities, and can enhance his image with both the physician and patient. Proper procedure are the following:

• 1. Receiving the prescription• 2. reading/checking the prescription• 3.Numbering and Dating

• 4. Labeling• 5. Preparing the prescription• 6.Packaging• 7. Rechecking the prescription• 8.Delivering the prescription• 9.Recording

Correct Prescription

• Brand names, if specified must also be spelt correctly.

• This is vital since entirely different drugs may have similar sounding brand names.

• It is preferable to write the word ‘Units’ in full ¾ an ‘U’ can be read off as ‘0’ leading to a ten-fold increase in dose! A decimal number less than 1 should always have a leading zero e.g. writing 0.5ml rather .5ml. The best option would be to avoid unnecessary use of the decimal point e.g. writing 500 mg instead of 0.5 g.

• Prescribing by generic / non-proprietary versus brand / proprietary names is a matter of perpetual controversy. Generic prescribing has several advantages. However, one may need to use a brand name if prescribing a formulation with multiple active ingredients or if the drug has critical bioavailability so that indiscriminate brand changes are not advisable. Some doctors also use brand names to be sure of the quality of medication being received by the patients. If a brand is specified it becomes imperative for the pharmacist to dispense that brand and not substitute another at will.

• The symbol "Rx" means "prescription" and is derived from the abbreviation "rx“ from the Latin word "to take", recipere. Literally, "Rx" is an instruction to the patient, "to take" what is specified in the prescription. The word "prescription" can be decomposed into "pre" and "script" and literally means, "to write before" a drug can be prepared. Those within the industry will often call prescriptions simply "scripts".

• As a guideline, pediatric prescriptions should include the age of the child if the patient is less than twelve and the age and months if less than five. (In general, including the age on the prescription is helpful.) In some jurisdictions, it may be a legal requirement to include the age of child on the prescription . Adding the weight of the child is also helpful.

• Who can write prescriptions• Who can issue prescriptions are governed by

local legislation. Some examples are: veterinarians, dentists, Ophthalmologists will also issue prescriptions for corrective eyeglasses, though technically these are not medical prescriptions.

• Writing good prescriptions• Independent of the actual prescribing decision,

elements of a good prescription writing include: careful use of decimal points to avoid ambiguity: – avoid unnecessary decimal points: 5 mL instead of 5.0

mL to avoid possible misinterpretation of 5.0=50 – always zero prefix decimals: e.g. 0.5 instead of .5 to

avoid misinterpretation with .5=5 – never have trailing zeros on decimals: e.g. use 0.5

instead of .50 to avoid misinterpretation with .50=50 – avoid decimals altogether by changing the units: 0.5 g

=500 mg

• Appendix 1: Complete List of Abbreviations• The listing here does not mean such

abbreviations should be used. This listing does not include abbreviations for actual pharmaceuticals (which is a separate article in itself.) Capitalization and the use of a period is a matter of style. In the attached list, Latin is not capitalized whereas English acronyms are.

• aa (ana) - of each • ad - to, up to• a.c. (ante cibium) - before meals • a.d. (aurio dextra) - right ear • ad lib. (ad libitum) - use as much as one

desires; • agit (agita) - stir/shake• alt. h. (alternis horis) - every other hour• a.m. (ante meridian) - morning, before noon

• amp - ampule • amt - amount • aq (aqua) – water • A.T.C. - around the clock • a.u. (auris utrae) - both ears bis (bis) –• twice b.i.d. (bis in die) - twice daily • B.M. - bowel movement • bol. (bolus) - a large pill • B.S. - blood sugar• B.S.A - body surface areas• cap., caps. (capsula) - capsule c (cum) - with (usually

written with a bar on top of the "c")

• c (cibos) – food• cc - cubic centimetre; • D.A.W. - dispense as written• dc, D/C, • disc - discontinue • dieb. alt. (diebus alternis) - every other day dil. -

dilute • disp. - dispense • div. - divide • d.t.d. (dentur tales doses) - give of such doses

• e.m.p. (ex modo prescripto) - as directed• emuls. (emulsum) – emulsion • fld. - fluid • ft. (fiat) - make; • g – gram• G.I. - gastrointestinal • gr – grain• gtt(s) (gutta(e)) - drop(s) • G.U. - gentiourinary • H – hypodermic

• h.s. (hora somni) - at bedtime • HTN - hypertension • ID - intradermal • IM - intramuscular (with respect to injections)

inj. (injectio) – injection• IP - intraperitoneal • IV - intravenous

• mcg - microgram • mEq – milliequivalent• mg – milligram• nebul (nebula) - a spray • N.K.A. - no known allergies• N.K.D.A. - no known drug allergies• N.M.T. - not more than• noct. (nocte) - at night • non rep. (non repetatur) - no repeats• NPO, n.p.o. (non per os) - nothing by mouth •

• q.i.d. (quater in die) - four times a day• q.o.d. - every other day• q.s. (quantum sufficiat) - a sufficient quantity • R- rectal • sig - write on label • SL - sublingually, under the tongue • sol (solutio) - solution • s.o.s., si op. sit (si opus sit) - if there is a need

supp (suppositorium) – suppository• susp - supsension

• syr (syrupus) – syrup• tab (tabella) - tablet tal.,• tbsp – tablespoon• troche (trochiscus) - lozenge • tsp - teaspoon • t.i.d. (ter in die) - three times a day• t.i.w. - three times a week• top. - topical • T.P.N. - total parenteral nutrition • tinc., tinct. - tincture • u.d., ut. dict. (ut dictum) - as directed • ung. (unguentum) – ointment • U.S.P. - United States Pharmacopeia • W.B.C. - white blood count • w/o - without • Y.O. - years old

• T.P.N. - total parenteral nutrition • tinc., tinct. - tincture • u.d., ut. dict. (ut dictum) - as directed • ung. (unguentum) – ointment • U.S.P. - United States Pharmacopeia • W.B.C. - white blood count • w/o - without • Y.O. - years old

Generic Dispensing Flow Chart

• If prescription is fully filled, retain prescription and file for 2 years.If prescription is partially filled, indicate the number dispensed in prescription and return it to the patient.

RA 66 75 : GENERIC ACT OF 1988

• promotes, requires, ensures the production of adequate supply, distribution, use and acceptance of drugs and medicines identified by their generic names.

• A generic drug (generic drugs, short: generics) is a drug defined as "a drug product that is comparable to brand/reference listed drug product in dosage form, strength, route of administration, quality and performance characteristics, and intended use."[1] It has also been defined as a term referring to any drug marketed under its chemical name without advertising.[2]

• Generic Name or Generic Terminology" is the identification of drugs and medicines by their scientifically and internationally recognize active ingredients or by their official generic name as determined by the Bureau of Food and Drugs of the Department of Health.

• Active Ingredient" is the chemical component responsible for the claimed therapeutic effect of the pharmaceutical product.

• Chemical Name" is the description of the chemical structure of the drug or medicine and serves as the complete identification of a compound.

• ADMINISTRATIVE ORDER • No. 63 s. 1989 • SUBJECT: Rules and Regulations to Implement

Dispensing Requirements • under the Generics Act of 1988 (R.A. No. 6675

• Pursuant to Section 9 in relation to Section 6 (a) and 6 (d) of R.A. 6675 known as

• “Generics Act of 1988”, and the pertinent provisions of R.A. 3720 known as “Food, Drugs

and Devices and Cosmetics Act", as amended by Executive Order No. 175 s 1987, RA

5921 known as the Pharmacy Act of 1972, as amended, the following rules and

regulations are hereby promulgated.

• “Dispensing” • is the act by a validly-registered pharmacist of

filling a prescription or doctor's order on the patient's chart.

“Generic Dispensing” Means dispensing the patient's/buyer's choice from among generic equivalents, i.e., finished pharmaceutical products having the same active

ingredient(s), same dosage form and same strength as the prescribed drug

Section 2 Guidelines On Dispensing Based on Prior Laws

• Prior to the Generic Act of 1988, the following general guidelines on dispensing have been operative. In order to have an Integrated implementation of all relevant guidelines on dispensing, these guidelines based on prior laws are restated hereunder:

• 2.1. Prescription or Ethical Drugs • These drugs can only be dispensed upon a

written order of a validly-registered physician, dentist or veterinarian

• 2.2 Non-Prescription or Over-the-Counter (OTC) Drugs

• These drugs may be dispensed even without a written order of a validly-registered physician, dentist or veterinarian in duly licensed drug outlets. When dispensing OTC drugs without a doctor's prescription, the pharmacist shall give the necessary information and direction for use of the drug

• 2.3. All prescriptions dispensed in the drugstore, • botica or hospital • pharmacy shall be kept in file for two years and re• corded in a prescription book duly-registered by

BFAD which shall be open for inspection to Food and Drug Inspectors at any time during business

• hours of the outlet. The prescription book shall be kept for two years after the last entry.

• Section 3. • Additional Guidelines on Dispensing to

Implement the Generics Act of 1988

• In addition to the guidelines contained in Section 2, the following shall specifically guide dispensing under the Generics Act of 1988

• 3.1. All drug outlets are required to practice generic dispensing as defined in Section 1.2 of these Rules and Regulations, with some

exceptions, modifications or qualifications in certain cases or circumstances, as described in Section 3.2 and 3.4

• 3.1.1. Drug Stores, Boticas, and other Drug Outlets In order to ensure the informed choice and use of drugs by the patient/buyer, the drug outlet is required to:

• .1.1.1. Inform the patient/buyer of all available drug products generically equivalent to the one prescribed with their corresponding prices. In so doing, the drug outlet shall not favor or suggest a any particular product so that the patient/buyer may

fully and adequately exercise his option to choose

• 3.1.1.2. For this purpose, all drug outlets shall • post in a conspicuous place in their

establishment a list of drug products using generic names with their corresponding current prices. A hand-book or directory containing the above required information

, readily accessible to the patient/buyer shall be considered substantial compliance.

• Hospital Pharmacies • Recognizing the special needs and

circumstances of hospitals, the following modified rules and regulations shall

• govern generic dispensing in hospital pharmacies, in the case of in-patients only

• 3.1.2.1. Upon admission, the patient or his/her responsible relative shall indicate in writing whether he/she shall submit to the hospital drug policies or reserve the

• option to buy drugs and medicines outside of the hospital pharmacy.

• 3.1.2.2. Hospital pharmacies operating on an acceptable formulary system and pricing policy as determined by the Department of Health (DOH), and using generic terminology in procurement, prescribing, dispensing, and recording of drugs, shall be exempted from the following

• 3.1.2.2.1. Recording of prescriptions filled in the prescription book, provided such prescription book, provided such prescriptions shall be kept in file for two years.

• .1.2.2.2. Individually informing the in-patient/buyer on the available generic equivalents and their corresponding prices. However, a handbook or directory containing the required drug information must be made available in the wards for patients, responsible relatives of patients, and professional

staff

• 3.2. In dispensing to the buyer, drug products in unit dose or products which are not in their original containers but transferred to small

bottles, tin cans, boxes, plastic and/or paper envelopes and the like the pharmacist shall place legibly on the required drug outlet's label the following information

• 1. Name of the patient; • 2. Generic name of the drug; • 3. Brand name, if any; • 4. Manufacture; • 5. Dosage strength; • 6. Expiry date; • 7. Directions for use; and • 8. Name of pharmacist

• 3.3. In partial filling of the prescription, the following shall be written on the face of the

prescription: • 1. the date of partial filling. • 2. the quantity served and balance of the

prescription unserved; and • 3. name and address of the drugstore

• The partially-filled prescription shall be returned to the buyer after recording the partial filling in the prescription book. The drugstore which completes the filling of the prescription shall keep the prescription in file.

• 3.4. Dispensing drugs in List A and List B • In dispensing drugs included in List A (Prohibited and Regulated Drugs) and List B (Drugs Requiring

Strict Precautions in their Use), attached as Annex and B respectively, the following shall be observed:

• 3.4.1. Dispensing must be done by the pharmacist who shall affix his/her signature on the prescription filled.

• 3.4.2. The order and instructions of the doctor as written on the prescription, must be precisely followed.

• 3.4.3. Partial filling of prescription for drugs be longing to List A shall not be allowed.

• Section 4 Guidelines on what to do with violative, erroneous, and impossible

prescriptions

• 4.1. Violative and impossible prescriptions as defined in A.O. 62 (Generic Prescribing) shall not be filled.

• The pharmacist shall advise the prescriber of the problem and/or instruct the customer to get the proper prescription. These violative and wrong prescriptions shall be kept and reported by the pharmacist or other interested parties to the nearest DOH office for appropriate action.

• 4.2. Erroneous prescriptions shall be filled, but they shall also be kept and reported to the nearest DOH office for appropriate action

• SECTION 5 • Violations on the part of dispensers and outlets The following acts or omissions are considered

violations of these rules and regulations: • 5.1. Imposing a particular brand or product on

the buyer• 5.2. Inaccurate dispensing i.e. dispensing a drug product which does not meet the prescription as

to any or all of the following: active ingredient, dosage form and strength

• 5.3. failure to post or make accessible the required up-to-date information on drug products.

• 5.4. failure to adequately inform the buyer on available products that meet the prescription

• 5.5. failure to indicate the generic name/official name designated by BFAD and other required information on the drug outlet's label of the dispensed drug

• 5.6. failure to record and keep prescriptions filled.

• 5.7. failure to report to the nearest DOH office• cases of violative, erroneous, and/or wrong

prescriptions within three months after • receipt of such prescriptions

• SECTION 6 • Reporting and Monitoring of Non-Compliance • Any interested party may report any verifiable

violation of these Rules and Regulations to the nearest DOH office. the local DOH office is

responsible for giving notice to erring pharmacists/outlets and for transmitting the report on violations to the Secretary of Health or the fiscal's office for appropriate action

• SECTION 7 • Administrative Sanctions • For violation of these Rules and Regulations,

the following sanctions, after due notice and summary hearing, may be imposed:

• 7.1. Suspension, or revocation of the license to operate the drug outlet by the Secretary of Health.

• 7.2. Professionals directly involved in the violations shall be recommended by Secretary of Health for appropriate administrative

sanctions by the PRC

• SECTION 8 • Criminal Liability • The imposition of the above sanctions does not

preclude the institution of appropriate criminal proceedings pursuant to Section 12 of RA 6675 known as the Generics Act of 1988, RA 3720 known as "Food, Drugs and Devices and Cosmetics Act" as amended and R.A. 5921 know as "Pharmacy Law" as amended, R.A. 6425 known as the Dangerous Drugs Act of 1972 as amended and other relevant laws, by the regional health office concerned, upon receipt of complaints or reports of violations.

• ECTION 9 • Timetable of Implementation • In order to give all affected parties adequate

time for learning and adjustment, the implementation of these Rules and Regulations shall be in three phases, as follows:

• Phase I • Education Drive and Information Dissemination This phase shall be from the date of the affectivity of

these Rules and Regulations to May 31, 1989. During this period, the DOH, in cooperation with the Department of Education, Culture and Sports, the Department of Local Government, and The Philippine Information Agency, shall undertake an education drive and information dissemination concerning the provisions of these Rules and Regulations as well as the Generics Act of

1988

• Phase 2 • Monitoring of Compliance without Sanctions or

Penalties

• From June 1, 1989 to August 31, 1989, the DOH shall Monitor voluntary compliance with the provisions of the Rules and Regulations on Prescribing and Dispensing. During this period, the associations of affected professionals are enjoined to promote compliance in order to achieve a smooth transition to the next phase of full implementation.

• Phase 3 • Full Implementation • Beginning September 1, 1989, the DOH and

the other Relevant agencies of government shall monitor compliance with these Rules and Regulations and all violations shall be subject to the appropriate sanctions and penalties provided for under these Rules and Regulations and the Generics Act of 1988

• SECTION 10 • Reparability Clause In case any provision of this Administrative

Order is declared contrary to law or unconstitutional, other provisions which are

not affected thereby shall continue to be in force and in effect

• SECTION 11 • Repealing Clause• All administrative orders, rules and regulations

and other administrative issuances or parts thereof inconsistent with the provisions of this A.O. are hereby repealed or modified accordingly

• SECTION 12 • Effectivity• This order shall take effect fifteen days after its

publication in two newspapers of general circulation.

• (Sgd) ALFREDO R.A. BENGZON • Secretary

• The following agencies are responsible in the promotion of generic names for pharmaceutical products

• DOH – inform the public• Govt agencies/ personnel- transactions• Medical/ dental/ vet. Practitioners- generic

prescribing• Manufacturing companies – generic labeling• Drug outlets – generic dispensing

Generic Dispensingflowchart (OTC)

Generic Dispensingflowchart (OTC)

• Pharmaceutical Equivalent

• Same generic name• Same molar amount• Same dosage form• Same active ingredient• Same route of administration

• Pharmaceutical alternative

• Same generic name• Different dosage form• Different chemical form/ salt

• Therapeutic equivalent

• Either the drug product is pharmaceutical equivalent or alternative but of same effect or indication

• Having the same effect is checked by:• Post marketing surveillance, clinical trials ,same

bioavailability• Ex: Leading Rifampicin products are not

Bioavailable, causing multiple resistance to TB patient

Violation of generic prescribing

• Violative• Generic name is not written• Generic name is not legible, while brandname

is legibly written• The brand name is indicated, “ nosubstitution”

is indicated

• Erroneous• Brand name precedes the generic name• Generic name is in the parenthesis• Brand name is not in the parenthesis• When more than two drug products are

prescribed per Rx form

• Impossible

• When only the generic name is written but not legible

• When generic name does not match the brand name

• Both generic name/ brand name are not legible• When the drug product is not registered with

BFAD